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| CLINICAL DEVELOPMENT PIPELINE | |
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HGS has a well balanced and deep portfolio of novel drugs directed toward diseases that represent significant unmet medical need. Three of these products are in late-stage development. BENLYSTA™ (belimumab) has successfully completed Phase 3 development in systemic lupus. We and GlaxoSmithKline (GSK) expect to submit marketing applications in the United States, Europe and other regions in the second quarter of 2010. ZALBIN™ (albinterferon alfa-2b) has successfully completed Phase 3 development in chronic hepatitis C. We have submitted a Biologics License Application to the FDA for ZALBIN in the United States and have received confirmation that our submission was accepted for filing with a PDUFA target date of October 4, 2010. Novartis has submitted a Marketing Authorization Application to the EMEA in Europe under the brand name JOULFERON®. In May, we submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax. We received a Complete Response Letter in November 2009 and continue to work closely with the FDA to obtain approval for raxibacumab. Right behind these late-stage products is an emerging high-potential mid-stage pipeline, led by our anti-cancer products, mapatumumab, a TRAIL receptor antibody, and HGS 1029, an IAP inhibitor. We also have substantial financial rights to a number of products in the GSK clinical pipeline. GSK is currently conducting Phase 3 clinical trials of darapladib in men and women with chronic coronary heart disease and Syncria® (albiglutide) in patients with type 2 diabetes mellitus.
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